Independent and Combined Effects of Resistance Exercise Training and β-hydroxy β-methylbutyrate Plus Vitamin D

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Aging; Skeletal Muscle

Treatments: Behavioral: Resistance Exercise Training; Dietary Supplement: Placebo; Behavioral: Non-Exercise Control; Dietary Supplement: HMB+VitD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03848741

093635

Details and patient eligibility

About

During middle-age, humans begin to lose muscle mass and strength. With increasing age the deterioration of muscle health is associated with a decline in quality of life and the loss of independence. β-hydroxy β-methylbutyrate (HMB) plus Vitamin D (VitD) have been proposed to increase skeletal muscle mass, contractile function and improve body composition but has yet to be evaluated in middle-aged women. The overall goal of this study is to determine the effects of HMB +VitD supplementation during 12 weeks of resistance exercise training or a non-exercise control on body composition, skeletal muscle size, and skeletal muscle function in middle-aged women.

Full description

To determine if HMB+VitD supplementation is an effective strategy to help prevent the loss of skeletal muscle size, skeletal muscle function and body composition in middle-aged women, forty eight women (45-60 yrs old) will be recruited to complete a 12-week intervention (n=12 per group; 4 groups). Participants will be randomized to complete a non-exercise control period or a resistance exercise training program. In a double-blinded fashion, participants in the non-exercise or resistance exercise groups will be randomized to consume either placebo or HMB+VitD. Before and after each intervention the investigators will evaluate skeletal muscle size, skeletal muscle function, and body composition.

Enrollment: 48 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women between 45 and 60 years old
• Women with a BMI < 35 kg/m2
• Sedentary (< 30 minutes of structured physical activity 3 times per week)
• Weight stable for 3 months prior (+/- 5kg)

Exclusion criteria

• Body mass index > 35 kg/m2
• Type 1 or Type 2 diabetes
• Uncontrolled hypertension
• Active cancer, cancer in remission, or having received treatment for any form of cancer in the previous 5 years
• Cardiovascular disease (e.g., peripheral artery disease and peripheral vascular disease)
• Uncontrolled thyroid function
• Chronic and/or regular consumption of medication known to influence skeletal muscle metabolism
• Use of Vitamin D (>2000 IU) or β-hydroxy β-methylbutyrate
• Tobacco use
• Any condition that limits exercise training (e.g., chronic obstructive pulmonary disease, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's disease, vertigo, dizziness)
• High alcohol consumption defined as more than 8 drinks per week for women
• Unwilling to undergo any study-related procedures
• Pregnancy
• Abnormal liver or kidney enzymes determined in blood chemistry panel
• Bleeding/clotting disorders or blood thinning medications (e.g., warfarin, heparin)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Non-exercise control with placebo

Placebo Comparator group

Description:

Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the β-hydroxy β-methylbutyrate (HMB) Plus Vitamin D (VitD) capsules.

Treatment:

Behavioral: Non-Exercise Control

Dietary Supplement: Placebo

Non-exercise control with HMB+VitD

Experimental group

Description:

Participants will be asked to maintain their normal physical activity and dietary habits during the 12-week intervention. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day.

Treatment:

Behavioral: Non-Exercise Control

Dietary Supplement: HMB+VitD

Resistance exercise training with placebo

Active Comparator group

Description:

Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 placebo capsules (calcium lactate), twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules \~30-60 minutes before resistance exercise. Placebo capsules match the size, color, weight, and number of capsules per dose compared to the HMB + VitD capsules.

Treatment:

Behavioral: Resistance Exercise Training

Dietary Supplement: Placebo

Resistance exercise training with HMB+VitD

Experimental group

Description:

Participants will complete 12-weeks (3 days per week) of a whole-body progressive resistance exercise training program. Physical activity, diet, urine and blood samples will be collected every 4 weeks. Each participant will consume 3 HMB+VitD capsules, twice a day with a meal or snack for a total of 6 capsules per day. Participants will be asked to take capsules \~30-60 minutes before resistance exercise. Each capsule contains 500 mg calcium HMB and 333.33 IU Vitamin D for a total of 3.0 g HMB and 2000 IU Vitamin D per day.

Treatment:

Behavioral: Resistance Exercise Training

Dietary Supplement: HMB+VitD